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Re: jq1234 post# 153788

Sunday, 12/09/2012 2:24:50 PM

Sunday, December 09, 2012 2:24:50 PM

Post# of 257566
In the IC arm, the median OS of the 5 HG non TN patients was ~11.3 months vs 5.5 months for the 6 HG TN patients. I find It hard to believe in the 5th or 6th line setting the type of chemo or TN status still makes such a big difference. Patients at this stage would be too refractory regardless of TN status. I am not sure whether it's correct to characterize chemo given to non-TN as active vs that to TN as placebo.


If this small sample based estimator were truly representative bigger patient population then I agree with your rationalization, which is a very good observation BTW.

However the sample size is too small.

Finally the way the crossover patients were analyzed in both control and cdx011 is a head scratcher. There is the inherent bias only patients who is fit or disease stable get the chance to cross over. The company must have felt it compelling to include such patients in both treatment arm as otherwise the PFS difference would be less pronounced. The correct way would be to censor on last SD visit before crossover and include in only the control arm.

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